Monday, December 15, 2008

The FDA On Combination Products (drug-biologic with medical device)

It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines."

Previous Posts:
Nice Review of US FDA Medical Device Regulation
Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending
FDA Guidance Documents - FDA Current Thinking (free)

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